Trial Outcomes & Findings for A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (NCT NCT04232553)

Last Updated: 2025-12-15

Results Overview

Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

996 participants

Primary outcome timeframe

Week 52

Results posted on

2025-12-15

Participant Flow

Eligibility for Study I6T-MC-AMAX (AMAX; NCT04232553) required completion of one of the originating studies: either Study I6T-MC-AMAM (AMAM; NCT03926130) or Study I6T-MC-AMAG (AMAG; NCT02891226). Participants from Study AMAM were classified as having achieved Endoscopic Response if they achieved a reduction from baseline in the Simple Endoscopic Score for Crohn's Disease \[SES-CD\] total score of greater than or equal to (\>=) 50% at Week 52.

(continued) Participants from Study AMAM were classified as not having achieved Endoscopic Response if they did not achieve a reduction from baseline in SES-CD total score \>= 50% at Week 52.

Participant milestones

Participant milestones
Measure	AMAM Mirikizumab (Miri): Miri 300 mg SC Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Placebo (PBO)/Miri: Miri 300 mg SC Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Ustekinumab (Uste): Miri 300 mg SC Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	All AMAG Participants: Miri 300 mg SC Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
Overall Study STARTED	287	222	29	34	138	109	18	53	106
Overall Study Received at Least One Dose of Study Drug	287	222	29	34	138	109	18	53	106
Overall Study COMPLETED	275	209	28	31	133	106	18	51	104
Overall Study NOT COMPLETED	12	13	1	3	5	3	0	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AMAM Mirikizumab (Miri): Miri 300 mg SC Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Placebo (PBO)/Miri: Miri 300 mg SC Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Ustekinumab (Uste): Miri 300 mg SC Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	All AMAG Participants: Miri 300 mg SC Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
Overall Study Adverse Event	3	2	1	2	1	1	0	0
Overall Study Death	0	1	0	1	0	0	0	0
Overall Study Lack of Efficacy	0	2	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	1	0	0	1	0	0	1
Overall Study Other - As reported by the investigator	0	1	0	0	0	0	0	0
Overall Study Physician Decision	1	1	0	0	1	0	0	0
Overall Study Pregnancy	1	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	7	5	0	0	2	2	2	0

Baseline Characteristics

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMAM Miri: Miri 300 mg SC n=287 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=222 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=29 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=34 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 300 mg SC n=138 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=109 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=53 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	All AMAG Participants: Miri 300 mg SC n=106 Participants Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.	Total n=996 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 12.84 • n=6009 Participants	38.4 years STANDARD_DEVIATION 13.66 • n=42 Participants	39.5 years STANDARD_DEVIATION 16.00 • n=77 Participants	37.7 years STANDARD_DEVIATION 11.92 • n=387 Participants	39.2 years STANDARD_DEVIATION 12.84 • n=160 Participants	37.6 years STANDARD_DEVIATION 12.68	37.6 years STANDARD_DEVIATION 9.52	38.0 years STANDARD_DEVIATION 12.88	41.5 years STANDARD_DEVIATION 12.20 • n=23 Participants	38.4 years STANDARD_DEVIATION 12.98 • n=42 Participants
Sex: Female, Male Female	124 Participants n=6009 Participants	88 Participants n=42 Participants	17 Participants n=77 Participants	11 Participants n=387 Participants	70 Participants n=160 Participants	54 Participants	7 Participants	21 Participants	49 Participants n=23 Participants	441 Participants n=42 Participants
Sex: Female, Male Male	163 Participants n=6009 Participants	134 Participants n=42 Participants	12 Participants n=77 Participants	23 Participants n=387 Participants	68 Participants n=160 Participants	55 Participants	11 Participants	32 Participants	57 Participants n=23 Participants	555 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	1 Participants	0 Participants	2 Participants	0 Participants n=23 Participants	6 Participants n=42 Participants
Race (NIH/OMB) Asian	68 Participants n=6009 Participants	61 Participants n=42 Participants	7 Participants n=77 Participants	5 Participants n=387 Participants	31 Participants n=160 Participants	21 Participants	3 Participants	6 Participants	13 Participants n=23 Participants	215 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	4 Participants n=6009 Participants	5 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	3 Participants n=160 Participants	3 Participants	0 Participants	0 Participants	7 Participants n=23 Participants	23 Participants n=42 Participants
Race (NIH/OMB) White	207 Participants n=6009 Participants	154 Participants n=42 Participants	21 Participants n=77 Participants	26 Participants n=387 Participants	102 Participants n=160 Participants	84 Participants	14 Participants	45 Participants	85 Participants n=23 Participants	738 Participants n=42 Participants
Race (NIH/OMB) More than one race	2 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	1 Participants n=23 Participants	4 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=6009 Participants	1 Participants n=42 Participants	1 Participants n=77 Participants	2 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	1 Participants	0 Participants	0 Participants n=23 Participants	10 Participants n=42 Participants
Region of Enrollment Argentina	1 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	1 Participants n=42 Participants
Region of Enrollment Australia	3 Participants n=6009 Participants	4 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	4 Participants	1 Participants n=23 Participants	13 Participants n=42 Participants
Region of Enrollment Austria	1 Participants n=6009 Participants	5 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	2 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	9 Participants n=42 Participants
Region of Enrollment Belgium	2 Participants n=6009 Participants	3 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	0 Participants n=160 Participants	1 Participants	0 Participants	1 Participants	3 Participants n=23 Participants	11 Participants n=42 Participants
Region of Enrollment Brazil	14 Participants n=6009 Participants	11 Participants n=42 Participants	0 Participants n=77 Participants	3 Participants n=387 Participants	7 Participants n=160 Participants	7 Participants	2 Participants	3 Participants	0 Participants n=23 Participants	47 Participants n=42 Participants
Region of Enrollment Canada	11 Participants n=6009 Participants	4 Participants n=42 Participants	4 Participants n=77 Participants	0 Participants n=387 Participants	5 Participants n=160 Participants	3 Participants	1 Participants	1 Participants	0 Participants n=23 Participants	29 Participants n=42 Participants
Region of Enrollment China	34 Participants n=6009 Participants	32 Participants n=42 Participants	5 Participants n=77 Participants	4 Participants n=387 Participants	10 Participants n=160 Participants	16 Participants	0 Participants	4 Participants	0 Participants n=23 Participants	105 Participants n=42 Participants
Region of Enrollment Croatia	5 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	5 Participants n=42 Participants
Region of Enrollment Czechia	12 Participants n=6009 Participants	14 Participants n=42 Participants	5 Participants n=77 Participants	2 Participants n=387 Participants	8 Participants n=160 Participants	7 Participants	2 Participants	2 Participants	6 Participants n=23 Participants	58 Participants n=42 Participants
Region of Enrollment France	1 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	3 Participants n=42 Participants
Region of Enrollment Germany	15 Participants n=6009 Participants	4 Participants n=42 Participants	1 Participants n=77 Participants	0 Participants n=387 Participants	2 Participants n=160 Participants	5 Participants	2 Participants	2 Participants	0 Participants n=23 Participants	31 Participants n=42 Participants
Region of Enrollment Hungary	10 Participants n=6009 Participants	3 Participants n=42 Participants	1 Participants n=77 Participants	1 Participants n=387 Participants	5 Participants n=160 Participants	5 Participants	1 Participants	1 Participants	4 Participants n=23 Participants	31 Participants n=42 Participants
Region of Enrollment India	4 Participants n=6009 Participants	6 Participants n=42 Participants	1 Participants n=77 Participants	0 Participants n=387 Participants	5 Participants n=160 Participants	1 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	17 Participants n=42 Participants
Region of Enrollment Israel	3 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants	1 Participants	0 Participants	3 Participants	0 Participants n=23 Participants	8 Participants n=42 Participants
Region of Enrollment Italy	1 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	3 Participants n=42 Participants
Region of Enrollment Japan	6 Participants n=6009 Participants	5 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	9 Participants n=160 Participants	2 Participants	0 Participants	1 Participants	13 Participants n=23 Participants	37 Participants n=42 Participants
Region of Enrollment Latvia	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	2 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	2 Participants n=42 Participants
Region of Enrollment Lithuania	1 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	0 Participants	0 Participants	1 Participants	0 Participants n=23 Participants	4 Participants n=42 Participants
Region of Enrollment Mexico	3 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	1 Participants	0 Participants	1 Participants	0 Participants n=23 Participants	7 Participants n=42 Participants
Region of Enrollment Netherlands	0 Participants n=6009 Participants	1 Participants n=42 Participants	1 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	5 Participants n=23 Participants	8 Participants n=42 Participants
Region of Enrollment Poland	40 Participants n=6009 Participants	33 Participants n=42 Participants	0 Participants n=77 Participants	4 Participants n=387 Participants	17 Participants n=160 Participants	22 Participants	2 Participants	8 Participants	16 Participants n=23 Participants	142 Participants n=42 Participants
Region of Enrollment Romania	5 Participants n=6009 Participants	5 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	1 Participants n=160 Participants	1 Participants	1 Participants	0 Participants	4 Participants n=23 Participants	17 Participants n=42 Participants
Region of Enrollment Russia	18 Participants n=6009 Participants	18 Participants n=42 Participants	2 Participants n=77 Participants	5 Participants n=387 Participants	11 Participants n=160 Participants	5 Participants	1 Participants	8 Participants	6 Participants n=23 Participants	74 Participants n=42 Participants
Region of Enrollment Serbia	4 Participants n=6009 Participants	1 Participants n=42 Participants	4 Participants n=77 Participants	2 Participants n=387 Participants	3 Participants n=160 Participants	2 Participants	0 Participants	2 Participants	0 Participants n=23 Participants	18 Participants n=42 Participants
Region of Enrollment Slovakia	3 Participants n=6009 Participants	4 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	3 Participants n=160 Participants	3 Participants	0 Participants	1 Participants	0 Participants n=23 Participants	14 Participants n=42 Participants
Region of Enrollment South Korea	21 Participants n=6009 Participants	17 Participants n=42 Participants	1 Participants n=77 Participants	0 Participants n=387 Participants	6 Participants n=160 Participants	2 Participants	3 Participants	1 Participants	0 Participants n=23 Participants	51 Participants n=42 Participants
Region of Enrollment Switzerland	2 Participants n=6009 Participants	1 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants	2 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	6 Participants n=42 Participants
Region of Enrollment Turkey	15 Participants n=6009 Participants	9 Participants n=42 Participants	1 Participants n=77 Participants	1 Participants n=387 Participants	1 Participants n=160 Participants	5 Participants	0 Participants	2 Participants	0 Participants n=23 Participants	34 Participants n=42 Participants
Region of Enrollment Ukraine	22 Participants n=6009 Participants	11 Participants n=42 Participants	2 Participants n=77 Participants	3 Participants n=387 Participants	18 Participants n=160 Participants	11 Participants	2 Participants	1 Participants	13 Participants n=23 Participants	83 Participants n=42 Participants
Region of Enrollment United Kingdom	4 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants	0 Participants n=160 Participants	0 Participants	0 Participants	0 Participants	0 Participants n=23 Participants	4 Participants n=42 Participants
Region of Enrollment United States	26 Participants n=6009 Participants	26 Participants n=42 Participants	1 Participants n=77 Participants	3 Participants n=387 Participants	19 Participants n=160 Participants	7 Participants	1 Participants	6 Participants	35 Participants n=23 Participants	124 Participants n=42 Participants

PRIMARY outcome

Timeframe: Week 52

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=132 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=97 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=49 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=269 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=195 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=31 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)	75.0 percentage of participants Interval 67.3 to 82.7	39.7 percentage of participants Interval 29.6 to 49.8	94.1 percentage of participants Interval 82.6 to 100.0	51.4 percentage of participants Interval 36.9 to 65.8	82.1 percentage of participants Interval 77.4 to 86.8	29.7 percentage of participants Interval 23.0 to 36.4	92.6 percentage of participants Interval 82.7 to 100.0	38.7 percentage of participants Interval 23.7 to 56.2

PRIMARY outcome

Timeframe: Week 52

Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score \< (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=132 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=97 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=49 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=269 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=195 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=31 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Percentage of Participants Achieving Clinical Remission at Week 52 (Participants Originating From AMAM Study)	75.8 percentage of participants Interval 67.9 to 83.6	74.6 percentage of participants Interval 65.2 to 84.0	84.9 percentage of participants Interval 65.3 to 100.0	68.5 percentage of participants Interval 53.8 to 83.1	79.2 percentage of participants Interval 74.1 to 84.4	65.9 percentage of participants Interval 58.8 to 72.9	76.6 percentage of participants Interval 60.1 to 93.2	55.9 percentage of participants Interval 37.6 to 74.2

SECONDARY outcome

Timeframe: Week 52

Alternate endoscopic remission is defined as SES-CD Total Score ≤4 with at least a 2-point reduction from the AMAM study baseline and no subscore \>1. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore \>1 is defined as no individual assessment score \>1 across all 20 individual assessments.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=132 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=97 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=49 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=269 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=195 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=31 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Percentage of Participants Achieving Alternate Endoscopic Remission at Week 52 (Participants Originating From AMAM Study)	47.1 percentage of participants Interval 38.3 to 56.0	22.1 percentage of participants Interval 13.5 to 30.6	63.1 percentage of participants Interval 39.6 to 86.6	32.6 percentage of participants Interval 19.0 to 46.1	54.6 percentage of participants Interval 48.4 to 60.7	14.2 percentage of participants Interval 9.1 to 19.3	66.3 percentage of participants Interval 48.0 to 84.5	25.8 percentage of participants Interval 13.7 to 43.2

SECONDARY outcome

Timeframe: Week 52

Clinical response by Patient Reported Outcome (PRO) was defined as a ≥30% decrease from baseline in stool frequency (SF) and/or abdominal pain (AP) score, with neither symptom worsening from baseline. SF was measured as the number of liquid or very soft stools per day. AP was scored daily on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=132 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=97 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=49 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=269 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=195 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=31 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Percentage of Participants Achieving Clinical Response by Patient Reported Outcome (PRO) at Week 52 - (Participants Originating From AMAM Study)	86.2 percentage of participants Interval 80.1 to 92.3	84.0 percentage of participants Interval 76.6 to 91.5	97.8 percentage of participants Interval 86.4 to 100.0	78.2 percentage of participants Interval 66.0 to 90.3	87.3 percentage of participants Interval 83.1 to 91.4	74.7 percentage of participants Interval 68.4 to 81.0	88.9 percentage of participants Interval 76.8 to 100.0	63.3 percentage of participants Interval 45.7 to 81.0

SECONDARY outcome

Timeframe: Week 12

Fecal calprotectin is an indicator of inflammation in the intestines with higher levels indicative of higher levels of inflammation.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=111 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=82 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=13 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=42 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=230 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=169 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=27 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=27 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Fecal Calprotectin at Week 12 (Participants Originating From AMAM Study)	113.0 micrograms per gram (μg/g) Interval 40.0 to 364.0	312.5 micrograms per gram (μg/g) Interval 85.0 to 834.0	46.0 micrograms per gram (μg/g) Interval 15.0 to 415.0	333.5 micrograms per gram (μg/g) Interval 67.0 to 984.0	110.5 micrograms per gram (μg/g) Interval 37.0 to 293.0	310.0 micrograms per gram (μg/g) Interval 104.0 to 962.0	134.0 micrograms per gram (μg/g) Interval 15.0 to 484.0	168.0 micrograms per gram (μg/g) Interval 62.0 to 761.0

SECONDARY outcome

Timeframe: Week 12

C-Reactive Protein is a biomarker of systemic inflammation measured in the blood, with elevated levels indicating increased inflammatory activity in the body.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=127 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=93 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=15 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=46 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=264 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=183 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
C-Reactive Protein (CRP) at Week 12 (Participants Originating From AMAM Study)	1.3 milligram per liter (mg/L) Interval 0.6 to 3.8	3.5 milligram per liter (mg/L) Interval 0.9 to 6.8	2.3 milligram per liter (mg/L) Interval 0.4 to 4.7	3.7 milligram per liter (mg/L) Interval 1.3 to 7.3	1.4 milligram per liter (mg/L) Interval 0.6 to 4.6	2.7 milligram per liter (mg/L) Interval 1.1 to 5.4	1.4 milligram per liter (mg/L) Interval 1.0 to 5.0	3.2 milligram per liter (mg/L) Interval 1.1 to 6.2

SECONDARY outcome

Timeframe: Baseline, Week 52

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item participant completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." IBDQ total score is calculated as the sum of all questions. Total scores range from 32 to 224; a higher score indicates a better quality of life.

Outcome measures

Outcome measures
Measure	AMAM Uste: Miri 300 mg SC n=132 Participants Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=97 Participants Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 Participants Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=49 Participants Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 300 mg SC n=269 Participants Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=195 Participants Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=28 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=31 Participants Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Change From Baseline in Health Related Quality of Life at Week 52 : Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Participants Originating From AMAM Study)	50.5 score on a scale Standard Error 2.82	49.9 score on a scale Standard Error 3.29	65.3 score on a scale Standard Error 7.84	46.4 score on a scale Standard Error 4.62	57.3 score on a scale Standard Error 1.99	46.1 score on a scale Standard Error 2.32	47.4 score on a scale Standard Error 6.12	38.6 score on a scale Standard Error 5.81

Adverse Events

AMAM Miri: Miri 300 mg SC

Serious events: 19 serious events

Other events: 189 other events

Deaths: 0 deaths

AMAM Miri: Miri 900 mg IV Then 300 mg SC

Serious events: 20 serious events

Other events: 138 other events

Deaths: 1 deaths

AMAM PBO/Miri: Miri 300 mg SC

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC

Serious events: 8 serious events

Other events: 21 other events

Deaths: 1 deaths

AMAM Uste: Miri 300 mg SC

Serious events: 9 serious events

Other events: 82 other events

Deaths: 0 deaths

AMAM Uste: Miri 900 mg IV Then 300 mg SC

Serious events: 9 serious events

Other events: 69 other events

Deaths: 0 deaths

AMAM PBO: Miri 300 mg SC

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

AMAM PBO: Miri 900 mg IV Then 300 mg SC

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

All AMAG Participants: Miri 300 mg SC

Serious events: 3 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMAM Miri: Miri 300 mg SC n=287 participants at risk Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=222 participants at risk Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=29 participants at risk Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=34 participants at risk Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 300 mg SC n=138 participants at risk Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=109 participants at risk Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 participants at risk Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=53 participants at risk Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	All AMAG Participants: Miri 300 mg SC n=106 participants at risk Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
Blood and lymphatic system disorders Anaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Deafness	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal fistula	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.8% 3/34 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ileal perforation	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ileal stenosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ileus	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Mechanical ileus	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Terminal ileitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anal abscess	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bacterial translocation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19 pneumonia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Dengue fever	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Enteritis infectious	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Post procedural infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pulmonary tuberculosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Transaminases increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Groin pain	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebellar infarction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Facial paresis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peroneal nerve palsy	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Sciatica	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Intrusive thoughts	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Schizoaffective disorder	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Uterine polyp	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/70 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Hysterectomy	0.81% 1/124 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	AMAM Miri: Miri 300 mg SC n=287 participants at risk Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Miri: Miri 900 mg IV Then 300 mg SC n=222 participants at risk Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 300 mg SC n=29 participants at risk Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC n=34 participants at risk Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 300 mg SC n=138 participants at risk Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM Uste: Miri 900 mg IV Then 300 mg SC n=109 participants at risk Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 300 mg SC n=18 participants at risk Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.	AMAM PBO: Miri 900 mg IV Then 300 mg SC n=53 participants at risk Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.	All AMAG Participants: Miri 300 mg SC n=106 participants at risk Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
Blood and lymphatic system disorders Iron deficiency anaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.70% 2/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	3.5% 10/287 • Number of events 10 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.8% 3/34 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 7/138 • Number of events 8 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 4/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Leukocytosis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Lymphopenia	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 5/222 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Splenomegaly	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.35% 1/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina pectoris	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Arrhythmia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Left ventricular dysfunction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Palpitations	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Tachycardia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Congenital, familial and genetic disorders Birth mark	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Congenital, familial and genetic disorders Gilbert's syndrome	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/163 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/134 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.5% 1/68 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/55 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/32 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Congenital, familial and genetic disorders Type v hyperlipidaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Motion sickness	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Vertigo positional	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Androgen deficiency	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Goitre	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hyperthyroidism	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hypothyroidism	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Polycystic ovarian syndrome	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/88 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Thyroid mass	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Blepharitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Cataract	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Chorioretinopathy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Conjunctivitis allergic	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Dacryoadenitis acquired	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Keratitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Macular degeneration	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Ocular hyperaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Panophthalmitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Periorbital oedema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Periorbital swelling	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Scleritis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Uveitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Visual acuity reduced	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Visual impairment	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	2.8% 8/287 • Number of events 8 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.1% 9/222 • Number of events 11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 4/138 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 4/106 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	3.8% 11/287 • Number of events 13 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal fissure	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal fistula	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal incontinence	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anal stenosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anorectal polyp	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Aphthous ulcer	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Chronic gastritis	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	1.7% 5/287 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 5/222 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 7/109 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dental caries	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	3.1% 9/287 • Number of events 9 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.1% 9/222 • Number of events 9 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 4/109 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Duodenitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Enteritis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Erosive oesophagitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Flatulence	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Food poisoning	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Frequent bowel movements	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastritis erosive	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival recession	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haematochezia	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 5/222 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ileal stenosis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Inflammatory bowel disease	0.35% 1/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal polyp	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal stenosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Large intestine erosion	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Large intestine polyp	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Mouth ulceration	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.70% 2/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Peptic ulcer	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Periodontal disease	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Proctalgia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Reflux gastritis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Subileus	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Terminal ileitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Toothache	2.1% 6/287 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 6/222 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Adverse drug reaction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Application site erythema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Application site pain	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest discomfort	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chills	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Cyst	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Drug intolerance	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Eye complication associated with device	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Face oedema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	1.4% 4/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 4/53 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Infusion site oedema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Infusion site pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Infusion site rash	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Infusion site reaction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site bruising	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site dermatitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site discharge	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site erythema	0.70% 2/287 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 15 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 28 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site haematoma	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site hypersensitivity	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site inflammation	0.35% 1/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site pain	1.7% 5/287 • Number of events 46 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 19 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 27 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site pruritus	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site rash	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site reaction	0.70% 2/287 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 5/138 • Number of events 31 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 8 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site swelling	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Localised oedema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Malaise	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Mass	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Medical device site inflammation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Peripheral swelling	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pseudopolyp	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	2.1% 6/287 • Number of events 9 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.1% 9/222 • Number of events 10 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 5/106 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Secretion discharge	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Swelling	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Tenderness	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Xerosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic cyst	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic failure	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic function abnormal	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic steatosis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hypertransaminasaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Liver disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Liver injury	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Allergy to animal	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Hypersensitivity	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Infusion related hypersensitivity reaction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Seasonal allergy	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Type ii hypersensitivity	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Abdominal abscess	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Acute sinusitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anal abscess	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Arthritis infective	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Clostridium difficile infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Conjunctivitis bacterial	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Coronavirus pneumonia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	12.2% 35/287 • Number of events 39 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.3% 25/222 • Number of events 26 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.7% 12/138 • Number of events 12 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.8% 14/109 • Number of events 14 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.2% 7/53 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.3% 12/106 • Number of events 12 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19 pneumonia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Dengue fever	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Ear infection	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Eczema infected	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Erysipelas	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Folliculitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Fungal skin infection	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Furuncle	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis	2.1% 6/287 • Number of events 9 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastrointestinal infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gingivitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Groin abscess	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Helicobacter infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes simplex	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Herpes zoster	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Hiv infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Hordeolum	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Impetigo	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Infected bite	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	2.1% 6/287 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Labyrinthitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Laryngitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Laryngopharyngitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Latent tuberculosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Mastitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasal herpes	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	6.6% 19/287 • Number of events 22 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 7/138 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.6% 5/109 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.4% 5/53 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.7% 6/106 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral herpes	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Otitis externa	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Otitis media	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Otitis media acute	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Paronychia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pericoronitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Periodontitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pharyngitis	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pharyngotonsillitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia aspiration	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Post procedural infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pulpitis dental	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rash pustular	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory tract infection viral	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rhinitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rhinovirus infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rotavirus infection	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Salpingo-oophoritis	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/54 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Scabies	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sepsis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sexually transmitted disease	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sinusitis	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 6/222 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/109 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Staphylococcal infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Staphylococcal skin infection	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Suspected covid-19	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tinea cruris	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tinea manuum	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tonsillitis	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tooth abscess	0.35% 1/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tooth infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	4.9% 14/287 • Number of events 18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.2% 16/222 • Number of events 20 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 7/138 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.6% 5/109 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	1.4% 4/287 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urosepsis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Varicella zoster virus infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral infection	1.4% 4/287 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/109 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral pharyngitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/88 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.0% 1/49 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod bite	1.0% 3/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Chemical burn	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Eye injury	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Eyelid injury	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Foreign body in throat	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Immunisation reaction	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Biopsy breast	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Mallet finger	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Muscle strain	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural site reaction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Scapula fracture	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Skin injury	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Soft tissue injury	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Thermal burn	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 4/106 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.35% 1/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alpha tumour necrosis factor increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Antinuclear antibody positive	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Ast/alt ratio abnormal	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bicarbonate decreased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood calcium decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood cholesterol decreased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood cholesterol increased	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	2.8% 8/287 • Number of events 10 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 6/222 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood folate decreased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood glucose increased	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood iron decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood potassium decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood pressure increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood triglycerides increased	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood uric acid increased	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Body temperature increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations C-reactive protein increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Hepatic enzyme increased	1.0% 3/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Hepatitis b dna assay positive	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations High density lipoprotein decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Interleukin level increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Liver function test increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Low density lipoprotein increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Lymphocyte count decreased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 2/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Lymphocyte count increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Neutrophil count decreased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Neutrophil count increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Procalcitonin increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Red blood cell sedimentation rate increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Reticulocyte count increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Sars-cov-2 test positive	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Staphylococcus test positive	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Transaminases increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Vitamin b12 decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Vitamin d decreased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight increased	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations White blood cell count decreased	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.7% 6/222 • Number of events 8 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations White blood cell count increased	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Carbohydrate intolerance	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Folate deficiency	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Gout	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	0.70% 2/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.35% 1/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.70% 2/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperlipidaemia	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.4% 4/287 • Number of events 10 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Insulin resistance	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Iron deficiency	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Vitamin b complex deficiency	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Vitamin b12 deficiency	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Vitamin d deficiency	0.35% 1/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 8/287 • Number of events 14 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.1% 9/222 • Number of events 11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 4/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	1.4% 4/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 4/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondropathy	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Costochondritis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Amnesia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint swelling	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	1.7% 5/287 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoporosis	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Periarthritis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal pain	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal neoplasm	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.81% 1/124 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Anosmia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Basal ganglia infarction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Burning feet syndrome	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebrovascular disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Disturbance in attention	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dysgeusia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	3.5% 10/287 • Number of events 13 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 8/222 • Number of events 8 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 4/109 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.4% 11/106 • Number of events 22 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Lumbar radiculopathy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Migraine	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Nerve compression	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Ophthalmic migraine	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Paraesthesia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Parosmia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Presyncope	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Radiculopathy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Sciatica	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Somnolence	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Tension headache	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Tremor	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Trigeminal neuralgia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Anxiety	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Anxiety disorder	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Bipolar disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depressed mood	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Hypersexuality	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	1.4% 4/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Sleep disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Stress	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Albuminuria	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Cystitis noninfective	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Glomerulonephritis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Hypertonic bladder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Micturition urgency	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	1.0% 3/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Pollakiuria	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Renal colic	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary tract inflammation	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urine odour abnormal	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.61% 1/163 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/134 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/68 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/55 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/32 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Cervical dysplasia	0.81% 1/124 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.0% 1/49 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Endometriosis	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 1/11 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/70 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/88 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.8% 1/21 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Pelvic fluid collection	0.81% 1/124 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Pelvic pain	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Penile pain	0.00% 0/163 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/134 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/68 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/55 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/32 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Prostatitis	0.61% 1/163 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/134 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/23 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/68 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/55 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/32 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/57 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.8% 1/21 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.8% 1/21 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/49 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Choking sensation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	2.1% 6/287 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 2/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.35% 1/287 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 3/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 3/29 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.0% 3/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/106 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Paranasal sinus inflammation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 2/29 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Actinic keratosis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Capillaritis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermal cyst	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	1.0% 3/287 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.90% 2/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hand dermatitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hidradenitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Leukonychia	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nodular rash	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 2/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	2.8% 8/287 • Number of events 9 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.8% 4/222 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.6% 5/138 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 4/109 • Number of events 5 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Sensitive skin	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin mass	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 3/222 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.4% 1/29 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 3/138 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria papular	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Social circumstances Food contamination	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Abscess drainage	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Anal fistula repair	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Blepharoplasty	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Cataract operation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Cholecystectomy	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.9% 1/34 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Colectomy	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Drainage	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Dupuytren's contracture operation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Fistula repair	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Haemorrhoid operation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Ileocolectomy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Intestinal anastomosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Intra-uterine contraceptive device insertion	0.00% 0/124 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/88 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/11 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/70 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/54 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/21 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.0% 1/49 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Keratomileusis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Laser therapy	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Liposuction	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Mass excision	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Medical device implantation	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Mole excision	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.94% 1/106 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Polypectomy	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Sinus operation	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Tenolysis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Tooth extraction	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 2/106 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Wisdom teeth removal	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Aortic aneurysm	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Aortic arteriosclerosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Brachiocephalic arteriosclerosis	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hot flush	0.35% 1/287 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hyperaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	2.1% 6/287 • Number of events 6 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.72% 1/138 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 3/109 • Number of events 3 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 4/106 • Number of events 4 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypotension	0.70% 2/287 • Number of events 2 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Ischaemia	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.92% 1/109 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Macroangiopathy	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.45% 1/222 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/53 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Varicose vein	0.00% 0/287 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/222 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/34 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/138 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/109 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/106 • Baseline Up to Week 52 * All enrolled participants who received at least one dose of study drug. As pre-specified in the statistical analysis plan (SAP), adverse events were reported by treatment regimen. * Gender specific events only occurring 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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60