Trial Outcomes & Findings for A Phase 1 Study of LY2835219 In Participants With Advanced Cancer (NCT NCT01394016)

NCT ID: NCT01394016

Last Updated: 2024-09-19

Results Overview

The number of participants with clinically significant findings in the study were reported in this outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 225 participants
• Primary outcome timeframe: Baseline up to 233 weeks
• Results posted on: 2024-09-19

Participant Flow

This study has Dose Escalation (Part A) and Dose Confirmation (Parts B, C, D, E, F, and G) phases. Participants included -Part A: participants with histological and cytological evidence of cancer; Part B: Non-small cell lung cancer; Part C: Glioblastoma multiforme; Part D: Advanced and/or metastatic breast cancer; Part E: Advanced and/or metastatic melanoma; Part F: Advanced and/or metastatic colorectal cancer. Part G: Advanced and/or metastatic breast cancer but also hormone receptor positive.

Completed is defined as for participants from Study Part-A: those who all completed one cycle of treatment or discontinued due to an adverse event and completed study follow up procedures, and for remaining all cohorts (B, C, D, E, F, G) who all were treated until disease progression (objective or symptomatic) or death or discontinued due to an adverse event and completed study follow-up procedures.

Participant milestones

Measure	Part A - Cohort 2: 100 mg Abemaciclib - Q24H Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Every 12 Hours (Q12H) Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 1: 50 Milligrams (mg) Abemaciclib - Every 24 Hours (Q24H) Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Overall Study STARTED	3	3	3	3	4	3	7	4	3	26	42	2	15	25	22	13	13	15	19
Overall Study Received At Least One Dose of Study Drug	3	3	3	3	4	3	7	4	3	26	42	2	15	25	22	13	13	15	19
Overall Study COMPLETED	3	3	3	3	4	3	6	2	2	24	38	2	14	22	21	10	11	13	16
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	2	1	2	4	0	1	3	1	3	2	2	3

Reasons for withdrawal

Measure	Part A - Cohort 2: 100 mg Abemaciclib - Q24H Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Every 12 Hours (Q12H) Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 1: 50 Milligrams (mg) Abemaciclib - Every 24 Hours (Q24H) Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Overall Study Progressive Disease	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1	0	1	1	4	0	0	3	1	3	1	1	2
Overall Study Adverse Event	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0
Overall Study Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

Baseline characteristics by cohort

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=4 Participants Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=3 Participants Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=3 Participants Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=3 Participants Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=3 Participants Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=4 Participants Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=3 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib- Q12H n=7 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H n=3 Participants Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H n=26 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H n=42 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H n=2 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H n=15 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H n=25 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H n=22 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H n=13 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H n=13 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H n=15 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H)+ Fulvestrant n=19 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Total n=225 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	11 Participants n=42 Participants	23 Participants n=42 Participants	0 Participants n=42 Participants	13 Participants n=36 Participants	18 Participants n=36 Participants	19 Participants n=24 Participants	5 Participants n=135 Participants	5 Participants n=136 Participants	8 Participants n=44 Participants	12 Participants n=667 Participants	136 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	15 Participants n=42 Participants	19 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=36 Participants	7 Participants n=36 Participants	3 Participants n=24 Participants	8 Participants n=135 Participants	8 Participants n=136 Participants	7 Participants n=44 Participants	7 Participants n=667 Participants	89 Participants n=15 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants	3 Participants n=42 Participants	15 Participants n=42 Participants	21 Participants n=42 Participants	1 Participants n=42 Participants	9 Participants n=36 Participants	24 Participants n=36 Participants	22 Participants n=24 Participants	3 Participants n=135 Participants	5 Participants n=136 Participants	9 Participants n=44 Participants	19 Participants n=667 Participants	150 Participants n=15 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	11 Participants n=42 Participants	21 Participants n=42 Participants	1 Participants n=42 Participants	6 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	10 Participants n=135 Participants	8 Participants n=136 Participants	6 Participants n=44 Participants	0 Participants n=667 Participants	75 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	4 Participants n=36 Participants	4 Participants n=24 Participants	2 Participants n=135 Participants	1 Participants n=136 Participants	3 Participants n=44 Participants	3 Participants n=667 Participants	27 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	7 Participants n=24 Participants	2 Participants n=42 Participants	24 Participants n=42 Participants	39 Participants n=42 Participants	2 Participants n=42 Participants	15 Participants n=36 Participants	21 Participants n=36 Participants	18 Participants n=24 Participants	11 Participants n=135 Participants	12 Participants n=136 Participants	11 Participants n=44 Participants	16 Participants n=667 Participants	197 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	1 Participants n=667 Participants	8 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	0 Participants n=667 Participants	5 Participants n=15 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	7 Participants n=24 Participants	2 Participants n=42 Participants	24 Participants n=42 Participants	39 Participants n=42 Participants	2 Participants n=42 Participants	15 Participants n=36 Participants	24 Participants n=36 Participants	20 Participants n=24 Participants	13 Participants n=135 Participants	13 Participants n=136 Participants	12 Participants n=44 Participants	18 Participants n=667 Participants	212 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=15 Participants
Region of Enrollment United States	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	7 Participants n=24 Participants	3 Participants n=42 Participants	26 Participants n=42 Participants	42 Participants n=42 Participants	2 Participants n=42 Participants	15 Participants n=36 Participants	25 Participants n=36 Participants	22 Participants n=24 Participants	13 Participants n=135 Participants	13 Participants n=136 Participants	15 Participants n=44 Participants	19 Participants n=667 Participants	225 Participants n=15 Participants

PRIMARY outcome

Timeframe: Baseline up to 233 weeks

Population: All participants who received at least one dose of the study drug.

The number of participants with clinically significant findings in the study were reported in this outcome measure.

Outcome measures

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=4 Participants Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=3 Participants Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=3 Participants Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=3 Participants Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=3 Participants Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=4 Participants Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=3 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n=7 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H n=3 Participants Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H n=26 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H n=42 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H n=2 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H n=15 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H n=25 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H n=22 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H n=13 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H n=13 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H n=15 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant n=19 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Number of Participants With Clinically Significant Effects	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	5 Participants	0 Participants	1 Participants	2 Participants	4 Participants	0 Participants	2 Participants	0 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline through Study Completion (Up to 285 weeks)

Population: All participants in Parts B, C, D, E, F and G who received at least one dose of the study drug.

ORR is the percentage of participants who exhibit a confirmed complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

DCR is defined as the percentage of participants in the analysis population who exhibit a stable disease (SD) or confirmed CR or PR relative to baseline during the study. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions.

Outcome measures

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=26 Participants Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=42 Participants Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=2 Participants Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=15 Participants Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=25 Participants Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=22 Participants Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=13 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n=13 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H n=15 Participants Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H n=11 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H n=8 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Percentage of Participants With Tumor Response - Overall Response Rate (ORR), Disease Control Rate (DCR) ORR	3.8 Percentage of participants Interval 0.1 to 19.6	2.4 Percentage of participants Interval 0.1 to 12.6	0 Percentage of participants 95% Confidence Interval (CI) was not calculable due to insufficient number of participants with events.	0 Percentage of participants 95% CI was not calculable due to insufficient number of participants with events.	32.0 Percentage of participants Interval 14.9 to 53.5	18.2 Percentage of participants Interval 5.2 to 40.3	0 Percentage of participants 95% CI was not calculable due to insufficient number of participants with events.	7.7 Percentage of participants Interval 0.2 to 36.0	0 Percentage of participants 95% CI was not calculable due to insufficient number of participants with events.	45.5 Percentage of participants Interval 16.7 to 76.6	0 Percentage of participants 95% CI was not calculable due to insufficient number of participants with events.	—	—	—	—	—	—	—	—
Percentage of Participants With Tumor Response - Overall Response Rate (ORR), Disease Control Rate (DCR) DCR	42.3 Percentage of participants Interval 23.4 to 63.1	52.4 Percentage of participants Interval 36.4 to 68.0	0 Percentage of participants 95% CI was not calculable due to insufficient number of participants with events.	20 Percentage of participants Interval 4.3 to 48.1	68.0 Percentage of participants Interval 46.5 to 85.1	72.7 Percentage of participants Interval 49.8 to 89.3	23.1 Percentage of participants Interval 5.0 to 53.8	30.8 Percentage of participants Interval 9.1 to 61.4	13.3 Percentage of participants Interval 1.7 to 40.5	72.7 Percentage of participants Interval 39.0 to 94.0	87.5 Percentage of participants Interval 47.3 to 99.7	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1

Population: PK analysis was conducted on participants who received the actual dose of Abemaciclib, irrespective of the treatment arm to which they were assigned, and had quantifiable data. So,4 participants from '200mg Abemaciclib' were reported under '100mg Abemaciclib' arm as they had their dose reduced to 100mg Abemaciclib. For 275mg Abemaciclib arm, 2 participants didn't have PK data collected on day 28, and dosing information was missing for remaining 1 participant. So, zero participants were analysed.

PK: Cmax,ss of Abemaciclib.

Outcome measures

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=2 Participants Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=3 Participants Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=3 Participants Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=3 Participants Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=3 Participants Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=8 Participants Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=72 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n=52 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Pharmacokinetics (PK): Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 28.6 ng/mL, 254 ng/mL.	102 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 198	189 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35	121 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 38	58.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 37	226 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51	249 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 86	298 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 72	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1

Population: PK analysis was conducted on participants who received the actual dose of Abemaciclib, irrespective of the treatment arm to which they were assigned, and had quantifiable data. So,4 participants from '200mg Abemaciclib' were reported under '100mg Abemaciclib' arm as they had their dose reduced to 100mg Abemaciclib. For 275mg Abemaciclib arm, 2 participants didn't have PK data collected on day 28, and dosing information was missing for remaining 1 participant. So, zero participants were analysed.

PK: AUC 0-24hr,ss of Abemaciclib.

Outcome measures

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=2 Participants Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=3 Participants Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=3 Participants Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=3 Participants Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=3 Participants Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=8 Participants Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=72 Participants Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n=52 Participants Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
PK: Area Under the Steady State Plasma Concentration-time Curve Over 24 Hours (AUC 0-24hr,ss) of Abemaciclib	NA nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 334 ng/mL, 4557 ng/mL.	1840 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 172	NA nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as only 2 participants had evaluable PK data. Individual values = 3448 ng/mL, 5162 ng/mL.	NA nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as only 2 participants had evaluable PK data. Individual values = 3164 ng/mL, 1576 ng/mL.	1300 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 49	3910 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 53	4280 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 94	5520 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 70	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline through Study Completion (Up to 285 weeks)

Population: All participants of Part A who received at least one dose of study drug.

The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from the study.

Outcome measures

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=33 Participants Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H Participants received 75 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Part A: Recommended Dose for Phase 2 Studies	200 milligrams every 12 hours (mg Q12H)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Part A - Cohort 1: 50 mg Abemaciclib - Q24H

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A - Cohort 2: 100 mg Abemaciclib - Q24H

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - Cohort 3: 150 mg Abemaciclib - Q24H

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - Cohort 4: 225 mg Abemaciclib - Q24H

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - Cohort 5: 75 mg Abemaciclib - Q12H

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - Cohort 6: 100 mg Abemaciclib - Q12H

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A - Cohort 7: 150 mg Abemaciclib - Q12H

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A - Cohort 8: 200 mg Abemaciclib - Q12H

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A - Cohort 9: 275 mg Abemaciclib - Q12H

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Part B - 150 mg Abemaciclib - Q12H

Serious events: 7 serious events

Other events: 26 other events

Deaths: 3 deaths

Part B - 200 mg Abemaciclib - Q12H

Serious events: 15 serious events

Other events: 42 other events

Deaths: 15 deaths

Part C - 150 mg Abemaciclib - Q12H

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part C - 200 mg Abemaciclib - Q12H

Serious events: 3 serious events

Other events: 15 other events

Deaths: 7 deaths

Part D - 150 mg Abemaciclib - Q12H

Serious events: 5 serious events

Other events: 25 other events

Deaths: 4 deaths

Part D - 200 mg Abemaciclib - Q12H

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Part E - 150 mg Abemaciclib - Q12H

Serious events: 5 serious events

Other events: 13 other events

Deaths: 1 deaths

Part E - 200 mg Abemaciclib - Q12H

Serious events: 5 serious events

Other events: 13 other events

Deaths: 5 deaths

Part F - 150 mg Abemaciclib - Q12H

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant

Serious events: 4 serious events

Other events: 19 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=4 participants at risk Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=3 participants at risk Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=3 participants at risk Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=3 participants at risk Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=3 participants at risk Participants received 75 mg of oral Abemaciclib administered every 12 hours (Q12H) on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=4 participants at risk Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=3 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n=7 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H n=3 participants at risk Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H n=26 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H n=42 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H n=2 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H n=15 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H n=25 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H n=22 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H n=13 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H n=13 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H n=15 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant n=19 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Duodenitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric antral vascular ectasia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abdominal wall abscess	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Large intestine infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Neutropenic sepsis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Osteomyelitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urosepsis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aphasia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Embolic stroke	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hemiparesis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Intracranial pressure increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Paraesthesia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Radiculopathy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Seizure	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Spinal cord compression	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mental disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hydroureter	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral coldness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n=4 participants at risk Participants received 50 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n=3 participants at risk Participants received 100 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n=3 participants at risk Participants received 150 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n=3 participants at risk Participants received 225 mg of oral Abemaciclib administered Q24H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n=3 participants at risk Participants received 75 mg of oral Abemaciclib administered every 12 hours (Q12H) on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n=4 participants at risk Participants received 100 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n=3 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n=7 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part A - Cohort 9: 275 mg Abemaciclib - Q12H n=3 participants at risk Participants received 275 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 150 mg Abemaciclib - Q12H n=26 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part B - 200 mg Abemaciclib - Q12H n=42 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 150 mg Abemaciclib - Q12H n=2 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part C - 200 mg Abemaciclib - Q12H n=15 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 150 mg Abemaciclib - Q12H n=25 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part D - 200 mg Abemaciclib - Q12H n=22 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 150 mg Abemaciclib - Q12H n=13 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part E - 200 mg Abemaciclib - Q12H n=13 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part F - 150 mg Abemaciclib - Q12H n=15 participants at risk Participants received 150 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant n=19 participants at risk Participants received 200 mg of oral Abemaciclib administered Q12H on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as a single dose on Day -3, every 12 hours on Days 1 to 27, and as a single dose on Day 28. The study drug was given along with 500 mg of fulvestrant administered intramuscularly during the treatment period. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion.
General disorders Catheter site pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Catheter site swelling	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oral herpes	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Otitis externa	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Incontinence	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Aortic aneurysm	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric antral vascular ectasia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Peritonitis bacterial	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Corneal dystrophy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Supraventricular tachycardia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eyelid ptosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Ventricular extrasystoles	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Glaucoma	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Pseudocholinesterase deficiency	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Ear pruritus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Hypoacusis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Cushingoid	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperparathyroidism	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hypothyroidism	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.2% 5/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.9% 5/42 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.3% 5/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Lymphocytic hypophysitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Blepharitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Conjunctival haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Conjunctivitis allergic	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Diplopia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Dry eye	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye discharge	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 13/26 • Number of events 17 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	59.5% 25/42 • Number of events 36 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 11/22 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.2% 6/13 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	38.5% 5/13 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 6/15 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.8% 7/19 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eyelid cyst	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Iron deficiency anaemia	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eyelid disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 7/42 • Number of events 19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eyelid function disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.0% 6/25 • Number of events 17 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 6/22 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.8% 10/42 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 14 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	45.5% 10/22 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.7% 4/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Angina pectoris	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial tachycardia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bradycardia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure congestive	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiomegaly	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiomyopathy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Coronary artery disease	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Palpitations	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 12/42 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.8% 7/22 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Catheter site discharge	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Keratitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Lacrimation increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Macular degeneration	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Macular oedema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Optic nerve disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Photopsia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Pterygium	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal detachment	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal oedema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vision blurred	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Visual impairment	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vitreous floaters	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal hernia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.1% 4/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.9% 7/26 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 6/22 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.8% 7/19 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Anal incontinence	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Angular cheilitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ascites	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Breath odour	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.7% 15/26 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	61.9% 26/42 • Number of events 28 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.7% 4/15 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.0% 7/25 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	45.5% 10/22 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	38.5% 5/13 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 6/15 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.3% 5/19 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Frequent bowel movements	25.0% 1/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dental caries	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 4/4 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 7/7 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	61.5% 16/26 • Number of events 17 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	69.0% 29/42 • Number of events 35 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	60.0% 9/15 • Number of events 18 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	84.0% 21/25 • Number of events 28 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	81.8% 18/22 • Number of events 27 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	69.2% 9/13 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 13/13 • Number of events 15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 10/15 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	89.5% 17/19 • Number of events 32 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticulum	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.8% 10/42 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Eructation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Faeces discoloured	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Flatulence	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric polyps	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric ulcer	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 13/26 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 14/42 • Number of events 14 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.0% 6/25 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 6/22 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.7% 7/15 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.1% 8/19 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gingival bleeding	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gingival pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Lip dry	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	85.7% 6/7 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	69.2% 18/26 • Number of events 22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	73.8% 31/42 • Number of events 36 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 6/15 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	76.0% 19/25 • Number of events 28 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	81.8% 18/22 • Number of events 21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 13/13 • Number of events 14 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	38.5% 5/13 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 10/15 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	94.7% 18/19 • Number of events 27 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oral disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oral pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Proctalgia	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Rectal discharge	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Varices oesophageal	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	34.6% 9/26 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	47.6% 20/42 • Number of events 24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 10/25 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	59.1% 13/22 • Number of events 18 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	47.4% 9/19 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Asthenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Axillary pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chills	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Early satiety	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Face oedema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	75.0% 3/4 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 4/4 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	71.4% 5/7 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	76.9% 20/26 • Number of events 24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	88.1% 37/42 • Number of events 53 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	93.3% 14/15 • Number of events 17 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	80.0% 20/25 • Number of events 30 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	77.3% 17/22 • Number of events 29 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	84.6% 11/13 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	69.2% 9/13 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 10/15 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	78.9% 15/19 • Number of events 31 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Gait disturbance	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Generalised oedema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Inflammation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Influenza like illness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site mass	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Malaise	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Mucosal inflammation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.1% 4/7 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.0% 6/25 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.9% 5/42 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Suprapubic pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Swelling	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Thirst	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatomegaly	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Allergy to arthropod sting	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Contrast media allergy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Drug hypersensitivity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	75.0% 3/4 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.9% 7/26 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 6/42 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.0% 7/25 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	45.5% 10/22 • Number of events 27 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	47.4% 9/19 • Number of events 17 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Food allergy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Hypersensitivity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Iodine allergy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Rubber sensitivity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Seasonal allergy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.0% 7/25 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.1% 4/19 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Anal infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Anorectal infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Candida infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Clostridium difficile colitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Device related infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Ear infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Enteritis infectious	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Eye infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Fungal skin infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastrointestinal infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastrointestinal viral infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gingivitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes simplex	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes zoster	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infected bite	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Localised infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nail infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pleural infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Rhinitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.3% 5/19 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tooth infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vaginal infection	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Viral infection	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Lymphatic duct injury	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Neck injury	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Recall phenomenon	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Amylase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	22.7% 5/22 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Bilirubin conjugated increased	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 6/26 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.4% 9/42 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood bilirubin increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood cholesterol increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.2% 6/13 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.1% 4/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood culture positive	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood testosterone decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood urea increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Breath sounds abnormal	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Cardiac murmur	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Ejection fraction decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Electrocardiogram qt prolonged	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Glomerular filtration rate decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Haemoglobin decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Hepatic enzyme increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations International normalised ratio decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations International normalised ratio increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Lymphocyte count decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 7/42 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Neutrophil count decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 18 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 6/22 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.6% 6/19 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Neutrophil count increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.2% 11/42 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	22.7% 5/22 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 6/26 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 43 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 6/22 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.1% 4/19 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count increased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.2% 12/26 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	54.8% 23/42 • Number of events 27 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	53.8% 7/13 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.2% 6/13 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 5/15 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.1% 8/19 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 12/42 • Number of events 14 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.8% 7/22 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.3% 5/19 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 7/42 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.7% 4/15 • Number of events 37 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.4% 8/22 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.8% 7/19 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Fluid retention	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Food aversion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Gout	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 8/26 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 12/42 • Number of events 17 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.8% 7/22 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.2% 6/13 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.8% 10/42 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 8/26 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.2% 11/42 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.9% 5/42 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypocholesterolaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Insulin resistance	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Obesity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	25.0% 1/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 5/15 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Vitamin d deficiency	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	22.7% 5/22 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	34.6% 9/26 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.0% 13/42 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.0% 7/25 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.8% 7/22 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.1% 4/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone deformity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Morphoea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 6/26 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 6/42 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vocal cord paralysis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.9% 5/42 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory carcinoma of the breast	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin neoplasm bleeding	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 4/26 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.0% 9/25 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.4% 8/22 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 6/15 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.9% 11/19 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour rupture	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Akathisia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Amnesia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aphasia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.7% 7/15 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ataxia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Brachial plexopathy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carotid artery stenosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral infarction	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cognitive disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dementia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Depressed level of consciousness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic neuropathy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Disturbance in attention	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.9% 5/42 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	22.7% 5/22 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysaesthesia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysarthria	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysgeusia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.2% 5/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dystonia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Epilepsy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Essential tremor	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Extrapyramidal disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Facial paralysis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Facial paresis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.2% 5/26 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.4% 9/42 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 10/15 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.0% 9/25 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 6/22 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	38.5% 5/13 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.8% 7/19 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hemiparesis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Memory impairment	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Migraine	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Migraine with aura	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Multiple sclerosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Muscle spasticity	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuralgia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Paraesthesia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Partial seizures	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Peripheral sensory neuropathy	75.0% 3/4 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	75.0% 3/4 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.9% 7/26 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.2% 11/42 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.0% 9/25 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	45.5% 10/22 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.7% 7/15 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Presyncope	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Psychogenic seizure	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Restless legs syndrome	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sciatica	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Seizure	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.7% 4/15 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Somnolence	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Taste disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Tremor	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.0% 3/25 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vocal cord paresis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Agitation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.1% 4/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 6/26 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 12/42 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 5/15 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.4% 8/22 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	63.2% 12/19 • Number of events 14 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.2% 12/26 • Number of events 13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	21.4% 9/42 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	46.7% 7/15 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.0% 7/25 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	45.5% 10/22 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	38.5% 5/13 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.9% 11/19 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Insomnia	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	34.6% 9/26 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	47.6% 20/42 • Number of events 20 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 5/15 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.0% 7/25 • Number of events 7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	54.5% 12/22 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	38.5% 5/13 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.3% 5/19 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mental disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mood swings	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mutism	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Nightmare	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Panic disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Personality change	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Sleep disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder spasm	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Chronic kidney disease	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Cystitis noninfective	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Cystitis ulcerative	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hydroureter	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hypertonic bladder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Micturition urgency	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Pollakiuria	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 6/42 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Proteinuria	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.6% 3/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal failure	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureteral spasm	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary hesitation	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary retention	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary tract pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Artificial menopause	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 2/21 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Breast pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Breast swelling	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 1/21 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Pelvic pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Prostatitis	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 1/1 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	— 0/0 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 1/1 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma exercise induced	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Granuloma annulare	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.3% 11/26 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	52.4% 22/42 • Number of events 23 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.0% 6/25 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.4% 8/22 • Number of events 9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	26.7% 4/15 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 6/42 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 13/26 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	54.8% 23/42 • Number of events 25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	24.0% 6/25 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	36.4% 8/22 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 6/42 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.8% 3/19 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.5% 3/26 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.8% 7/22 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Facial wasting	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nail growth abnormal	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	42.9% 3/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	8.0% 2/25 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	23.1% 3/13 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Seborrhoea	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin fragility	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	15.4% 2/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Social circumstances Menopause	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Social circumstances Postmenopause	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 1/6 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/21 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/24 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Brachiocephalic vein thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Diastolic hypotension	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Embolism	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Flushing	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	4.5% 1/22 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Haematoma	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hot flush	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	20.0% 5/25 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	100.0% 3/3 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 2/4 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.1% 4/7 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	57.7% 15/26 • Number of events 16 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	54.8% 23/42 • Number of events 25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	50.0% 1/2 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 6/15 • Number of events 12 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	32.0% 8/25 • Number of events 8 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	45.5% 10/22 • Number of events 11 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	30.8% 4/13 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	76.9% 10/13 • Number of events 10 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	40.0% 6/15 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	31.6% 6/19 • Number of events 6 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	11.9% 5/42 • Number of events 5 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 2/22 • Number of events 3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Jugular vein thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Lymphoedema	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	16.0% 4/25 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 4/22 • Number of events 4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 1/13 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Orthostatic hypotension	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral vascular disorder	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Raynaud's phenomenon	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Thrombosis	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Varicose vein	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/7 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/26 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/22 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/13 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline through End of Treatment (Up to 645 weeks) All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60